Enhertu (fam-trastuzumab deruxtecan-nxki) received FDA regular approval for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy.
FDA granted Priority Review for Imfinzi (durvalumab) in combination with standard-of-care chemotherapy, for patients with locally advanced or metastatic biliary tract cancer (BTC).
FDA granted Fast Track designation to HM43239, an oral, myeloid kinome inhibitor, for the treatment of patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with FLT3 mutation.
The European Commission approved Kymriah (tisagenlecleucel), a CAR-T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The European Commission has approved the use of Cabometyx (cabozantinib) as a monotherapy for the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma, refractory or not eligible to radioactive iodine who have progressed during or after prior systemic therapy.
Myriad Genetics Inc. expanded its partnership with Intermountain Precision Genomics to add a new liquid biopsy therapy selection test to its oncology portfolio.
Aadi Bioscience Inc. has received a product-specific, permanent J-code for Fyarro (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion and recommended granting marketing authorization for Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer harboring alterations leading to mesenchymal-epithelial-transition factor gene exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
Portage Biotech Inc., NCI, and Stimunity entered a Cooperative Research and Development Agreement, under which they will collaborate with NCI’s Center for Cancer Research to advance preclinical and potential clinical development of STING agonists and anti-Receptor for Advanced Glycation End products (RAGE) agents to enhance the efficacy of cancer vaccines developed in the NCI CCR Vaccine Branch.
FDA granted clearance to version 1.1 of the next generation SmartFrame Array Neuro Navigation System and Software, sponsored by ClearPoint Neuro Inc.
